Quality Assurance Engineer

IMDS; Roden; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

International environment

Challenging role

Training opportunities

Year-end bonus

Job summary

IMDS (Interventional Medical Device Solutions) in Roden, The Netherlands, is seeking a Quality Assurance Engineer to drive compliance across operations and New Product Development. You will review protocols, documents, and records while supporting CAPA, non-conformances, and internal audits in a multi-disciplinary setting.

The role requires a BSc/MSc in a relevant field, at least 2 years of medical device QA experience, and strong communication with manufacturing and development engineers.

Qualifications

• Clear and effective communication with cross-functional teams.
• Demonstrates ownership and accountability for quality outcomes.
• Ability to align cross-functional team members through collaboration.
• Strong written and oral English reporting and presentations.

Responsibilities

• Review of Engineering, Qualification- and Validation protocols and reports.
• Review of New Product Development documentation.
• Review of Specifications, Calibration- and Maintenance records.
• Maintenance of Quality Management Procedures, – Guidance’s and – Templates.
• Prepare and organize the Quality Management System Review meetings.
• Coordinate handling of Non-Conformance Records, CAPA’s and complaint investigations.
• Coordinate Cleanroom Monitoring and Corrective Actions.
• Coordinate Bioburden Monitoring, Endotoxin Monitoring and Periodic Dose Audits.
• Train new employees on Quality Management System.
• Prepare and execute internal audits (ISO 13485, cGMP) and DHF audits.

Skills

Communication

Ownership

Cross-functional collaboration

English reporting

Education

BSc/MSc in exact sciences

Job description

We offer a challenging position for a Quality Assurance Engineer professional in an innovation driven Medical Device Company. You are part of the IMDS QA/RA team where you take ownership for driving compliance with our operations – and development process and the quality of our products. You enjoy working in a multi-disciplinary environment, you are highly skilled in communication, and you have a can-do attitude. You realize that quality is of paramount importance and you are passionate about delivering solutions that truly stand out.

Tasks & Responsibilities:

The Quality Assurance Engineer participates both within an Operations environment as well as a New Product Development environment. Typical tasks for the Quality Assurance Engineer are:

• Review of Engineering -, Qualification- and Validation protocols and reports
• Review of New Product Development documentation
• Review of Specifications, Calibration- and Maintenance records
• Maintenance of Quality Management Procedures, – Guidance’s and – Templates
• Prepare and organize the Quality Management System Review meetings
• Coordinate handling of Non-Conformance Records, CAPA’s and complaint investigations
• Coordinate Cleanroom Monitoring and Corrective Actions
• Coordinate Bioburden Monitoring, Endotoxin Monitoring and Periodic Dose Audits
• Train new employees on Quality Management System
• Prepare and execute internal audits (ISO 13485, cGMP) and DHF audits

Job Requirements:

• BSc or MSc degree in exact sciences (e.g. Business Engineering)
• Strong feeling for an engineering environment
• Minimal 2 years of medical device work experience in QA
• Highly committed, respectful, trustful, eager and demonstrate ownership
• Creates alignment between cross functional team members through effective communication and seeks cross-function cooperation
• Has sufficient technical knowledge to enable high level communication with development– and manufacturing engineers
• Able to write clear reports in English, delivers presentations effectively to small and larger groups
• Can define objectives and break down into executable tasks with scheduling and tracking for overall plan execution; can prioritize activities by importance and meet tight deadlines.

About the Company:

IMDS (Interventional Medical Device Solutions) in Roden, The Netherlands, is an innovative and international high-tech organization and is dedicated to improving the patient outcome of percutaneous coronary interventions (PCI). With strong focus on game changing in-house technology, we develop unique product solutions enable advance treatment options. IMDS is equipped as a Centre of Excellence to develop, improve and manufacture innovative solutions for Medical Devices. When you join IMDS, you are part of a highly motivated team that helps to improve quality of life. IMDS offers the excitement and growth potential of an agile company with the strength and stability of an established industry leader. The environment is fluid and fast-paced and the people work together to make a difference every day. The atmosphere is friendly and team oriented. Working at IMDS gives you the opportunity to make a positive impact on the lives of others. IMDS is committed to building and maintaining a workforce that reflects the diversity of its global customer base.

We offer:

• Engaged international working environment in a modern working location
• Challenging job position with corresponding responsibilities
• Opportunity to take courses, for example, attend RAPS meetings and seminars
• A competitive remuneration package, including year-end bonus

Position in the organization:

Report to the Director QA/RA